Major European Regulatory
Andhra Pradesh ~ India ~ International ~ City ~ Entertainment ~ Business ~ Sports ~ Technology ~ Health ~ Features
Commonwealth Games ~ Nobel Prizes ~ Kim Jong-il ~ Hamid Karzai ~ Ed Miliband ~ Tony Abbott ~ Kathleen Sebelius ~ US Elections ~ Other International News
Home / International News / Press Releases / 2009 / November / November 27, 2009
Major European Regulatory Milestone in Cardiovascular Protection for MICARDIS® (telmisartan): Now Approved by the European Commission to Reduce the Risk of Cardiovascular (CV) Morbidity in High CV Risk Patients
Diabetes

Study to find whether leptin helps type 1 diabetic patients

Blame your mom for your muffin top or thunder thighs

Clinical trials show effective weight loss strategies for obese

More on Diabetes

Coronary heart disease

The humble red onion could help prevent heart disease

Poor kidney function linked to brain and heart problems

Chocolate eaters 'less likely to have heart disease'

More on Coronary heart disease

Heart attack

F1 legend James Hunt 'slept with 5,000 women'

A cuppa thrice a day can 'protect against heart attacks'

Loss of cell powerhouses linked to Parkinson's

More on Heart attack

Top News

144 Section in Hyderabad ahead of Ayodhya verdict

18 killed, several injured as bus falls into river in Bulandshahr

Pak's flawed Afghan policy of support to terror groups will bite back hard: Editorial

Ajay Devgan prays for success of his film in Ajmer

Pranab Mukherjee seeks more financial sector reforms

Australia asks CWG organizers for better treatment at closing ceremony

Study to find whether leptin helps type 1 diabetic patients

New study confirms smoking, cancer link (reissue)

Major European Regulatory Milestone in Cardiovascular Protection for MICARDIS® (telmisartan): Now Approved by the European Commission to Reduce the Risk of Cardiovascular (CV) Morbidity in High CV Risk Patients

Ingelheim, Germany

Boehringer Ingelheim announced today that the European Commission has approved MICARDIS® (telmisartan) for the reduction of cardiovascular morbidity in patients with:

I. manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or,

II. type 2 diabetes mellitus with documented target organ damage.

MICARDIS® is the first treatment in its class to be approved for this indication. The EMEA approval is the second major milestone for MICARDIS® in cardiovascular protection. It follows the approval by the US FDA for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors.

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy said, "This new indication of telmisartan is a significant development for physicians and their at-risk patients. Prevention of CV events is vital as these are the primary causes of pathological death in Europe, due to lack of proper control of treatable risk factors and disease. The approval of telmisartan offers patients a well-tolerated treatment option which also provides CV protection."

Professor Klaus Dugi, Corporate Vice President, Medical Affairs, Boehringer Ingelheim, commented, "We are delighted to receive this indication for MICARDIS® from the European Commission which closely follows the approval granted by the FDA in the US. These approvals clearly demonstrate the unique treatment option that MICARDIS now provides to both physicians and patients as the only medication in the ARB class to provide proven CV protection."

The European Commission approval is based upon a review of clinical trial results, including the ONTARGET trial involving 25,620 patients and confirmed MICARDIS® as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk.1 The results also demonstrated that MICARDIS® is better tolerated than the previous gold standard ramipril and is associated with higher treatment adherence.1-2

MICARDIS® has also received approval for CV protection in Bolivia, Canada, Chile, Mexico, Paraguay, Philippines, Thailand and Uruguay.

MICARDIS® is one of the most studied antihypertensives in clinical trials and is widely used with over five million patient years since its approval. Its safety profile is similar to that of placebo.

To view ‘Notes to Editors’ and References, please click on the link below:

http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7135

Source:Business Wire (Business Wire India)

Link to this page


Suggested pages for your additional reading
AndhraNews.net on Facebook






© 2000-2018 AndhraNews.net. All Rights Reserved and are of their respective owners.
Disclaimer, Terms of Service & Privacy Policy | Contact Us